Ultrasound Guided Transfemoral Complex Large-bore PCI Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 544
- 试验地点
- 10
- 主要终点
- Proportion of patients with BARC 2, 3 or 5 access-site related bleeding or vascular complication requiring intervention of the primary femoral access site during index hospitalization.
研究概览
简要总结
ULTRACOLOR is a randomized multicentre investigator-initiated study to investigate if ultrasound guided femoral access is associated with less clinically relevant access site related bleeding and/or vascular complications requiring intervention as compared to the fluoroscopy guided method for complex PCI with large-bore access.
详细描述
ULTRACOLOR is a prospective, multicentre, randomized investigator-initiated trial designed to enroll 542 subjects with an indication for PCI for complex coronary lesions.
This study will investigate if ultrasound guided femoral access is associated with less clinically relevant access site related bleeding and/or vascular complications requiring intervention as compared to the fluoroscopy guided method for complex PCI with large-bore access.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Use of the femoral artery for primary or secondary access with ≥ 7 Fr guiding catheter as indication for complex PCI, according to the expertise of the treating physician.
- •Age 18 years or older.
排除标准
- •Inability to obtain informed consent
- •Contra-indication for femoral access
- •Cardiogenic shock
- •ST elevation myocardial infarction
研究组 & 干预措施
ultrasound guided femoral access
Patients who are planned for complex PCI requiring 7 or more French sheath and guiding catheters. Ultrasound guided femoral access will be used.
干预措施: Ultrasound guided femoral access for complex PCI (Procedure)
fluoroscopy guided femoral access
Patients who are planned for complex PCI requiring 7 or more French sheath and guiding catheters. Fluoroscopy guided femoral access will be used.
干预措施: Fluoroscopy guided femoral access for complex PCI (Procedure)
结局指标
主要结局
Proportion of patients with BARC 2, 3 or 5 access-site related bleeding or vascular complication requiring intervention of the primary femoral access site during index hospitalization.
时间窗: up to discharge hospital, on average 24 hours
次要结局
- Procedural duration(during PCI procedure)
- Proportion of patients with BARC 2, 3 or 5 access-site related bleeding or vascular complication requiring intervention of the secondary femoral or radial access site at 1 month(1 month)
- Incidence of access below the femoral artery bifurcation (ileofemoral angiogram)(during PCI procedure)
- Proportion of patients with BARC 2, 3 or 5 access-site related bleeding or vascular complication requiring intervention of the secondary femoral or radial access site during index hospitalization.(up to discharge hospital, on average 24 hours)
- Proportion of patients with BARC 2, 3 or 5 access-site related bleeding or vascular complication requiring intervention of the primary femoral access site at 1 month.(1 month)
- Number of access attempts(during PCI procedure)
- Incidence of vascular complication not requiring intervention of the secondary femoral or radial access site(up to discharge hospital (on average 24 hours) and at 1 month)
- Proportion of patients with MACE(up to discharge hospital (on average 24 hours) and at 1 month)
- Incidence of first pass puncture(during PCI procedure)
- Incidence of vascular complication not requiring intervention of the primary femoral access site(up to discharge hospital (on average 24 hours) and at 1 month)
- Incidence of.accidental venipuncture(during PCI procedure)